FDA 483 - Gojo Industries - November 07, 2025

Gojo Industries in Wooster, OH, was inspected from November 3-7, 2025, and received a Form 483 with three observations. The inspection revealed significant deficiencies in laboratory controls, including inadequate impurity testing for bulk materials and finished drug products. Additionally, the firm's stability program lacked reliable test methods, and the quality control unit's responsibilities were not fully documented or followed, with the analytical laboratory manager holding conflicting administrative and testing roles.